FDA Suggests Removing Oral Phenylephrine as OTC Monograph Nasal Decongestant Ingredient

An announcement was made by the US Food and Drug Administration (FDA) that proposed a removal of the active ingredient oral phenylephrine in over-the-counter (OTC) monograph drug products for temporary nasal congestion relief.¹

The announcement urging phenylephrine as an active ingredient resulted from an agency review of existing data. This review by officials led to the conclusion that oral phenylephrine had not been shown to effectively relieve users’ nasal congestion.

“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, MD, the director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”¹

A commonly used ingredient, oral phenylephrine is currently featured in many OTC nasal decongestant medications. It is either implemented in such treatments as a single active ingredient or in combination with others, such as acetaminophen or dextromethorphan.

The ingredient’s presence in multi-ingredient formulations was noted in the FDA announcement as not affecting the function of these other active ingredients in their addressing of the intended symptoms. Their decision followed a review of extensive historical and recent data.

Despite older research conducted around 30 years ago supporting the use of oral phenylephrine for nasal decongestant treatments, FDA officials noted that more recent clinical evidence has suggested contrary conclusions. In fact, the agency’s Nonprescription Drug Advisory Committee convened for the purposes of discussing the ingredient's status under the “Generally Recognized as Safe and Effective” (GRASE) designation for use in nasal decongestants.

A unanimous agreement by the committee determined that current research does not suggest the effectiveness of oral phenylephrine at the recommended doses in products which are OTC. Additionally, it was noted that this proposal by the FDA does not impact phenylephrine nasal sprays, which remain approved for nasal congestion treatment.

Currently, FDA officials are now inviting public comments on the proposed order. Following a feedback review, the agency will issue its final order regarding phenylephrine’s use in the OTC monograph. If such a circumstance occurs, time would be provided to manufacturers to either reformulate products containing oral phenylephrine or withdraw such products from the market.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” Theresa Michele, MD, director of the Office of Nonprescription Drug Products in CDER, said in a statement. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”¹

References

1. ^{FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. US Food and Drug Administration. November 7, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after.}